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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004594
Receipt No. R000005369
Scientific Title Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer
Date of disclosure of the study information 2010/11/21
Last modified on 2010/11/20

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Basic information
Public title Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer
Acronym Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer
Scientific Title Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer
Scientific Title:Acronym Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The relationship among the atrophic change on endoscopic finding, interval of the precedures and gastric cancer
Basic objectives2 Others
Basic objectives -Others comparison among each group
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of gastric cancer in each group
Key secondary outcomes Pathohistrogical characteristics of the gastric cancer and the atrophic change on endoscopic finding

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pathient whose informed concent was obtained
Key exclusion criteria Patient whose infromed concent was not obtained
Target sample size 32000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Matsuda
Organization The Jikei University Aoto Hospital
Division name Department of endoscopy
Zip code
Address 6-41-2 Aoto, Katsushika, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Jikei University Aoto Hospital
Division name Department of protection of personal information
Zip code
Address
TEL 03-3603-2111
Homepage URL
Email

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Oda GI clinic, Kitasato University Hosptial East, Kyoto second red cross hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京慈恵会医科大学附属青戸病院(東京都)、尾田胃腸科内科(熊本県)、北里大学東病院(神奈川県)、京都第二日赤病院(京都府)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The atrophic change in the gastric mucosa on endoscopic finding has a potential to predict the high risk group for the gastric cancer. The careful endoscopic follow-up would be recommended in cases with severe atrophic change on endoscopy. However, the natural history seemed different between the intestinal or mixed type, and the gastric type.

Management information
Registered date
2010 Year 11 Month 20 Day
Last modified on
2010 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005369

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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